The Hawaii Administrative Rules $11-850-81 requires dispensary licensees to ensure their marijuana and marijuana products are tested by a laboratory certified by the Hawaii State Department of Health before dispensing. In addition, Hawaii Revised Statutes 329D-8 provides that the Hawaii State Department of Health initiates and implements standards for laboratory testing of marijuana and marijuana products. In accordance with this requirement, the department licenses marijuana testing laboratories to test cannabis and cannabis products for content, consistency, and contamination. In establishing these standards, the Hawaii State Department of Health shall:
The Hawaii Administrative Rules 11-850 requires certified testing laboratories to conduct specific tests to ensure the safety of cannabis products sold to registered patients in the state. These tests include:
Any other tests required by the Hawaii State Department of Health shall also be conducted.
Yes, Hawaii licenses independent testing facilities that qualify after the Hawaii State Department of Health has reviewed their applications. The state does not have a state agency that is responsible for testing marijuana and marijuana products. However, the Hawaii State Department of Health licenses and regulates certified testing facilities in the state. There are only four certified testing facilities in Hawaii, including Aeos Labs, MedCan Lab, AgLabs Hawaii, and Steep Hill.
Testing laboratories in Hawaii are required to meet the specific laboratory accreditation standards of the International Organization for Standardization (ISO). This entails possessing a certificate of ISO/IEC 17025:2017 accreditation and related audit reports by an approved accreditation or credentialing body. The ISO/IEC 17025:2017 accreditation is the international reference for testing laboratories. Entities looking to obtain certification from the State Department of Health to operate testing laboratories must be ISO/IEC 17025:2017 accredited. Otherwise, they may be accredited in Hawaii by an accreditation body whose standards are equivalent to the International Standards for Organization ISO 17025. They must also have established standard operating procedures that include a chain of custody for samples transferred to the laboratory for testing.
However, the department may grant a provisional certification to a laboratory to test marijuana and marijuana products provided the laboratory:
Has applied to be ISO 17025 accredited in International Standards for Organization (ISO);
Is owned or managed by a laboratory accredited in another jurisdiction by an accreditation body whose standards are similar to the ISO 17025; or
Has fulfilled all other criteria for the laboratory certification
The requirements for ISO-IEC 17025:2017 accreditation include:
1. General requirements
This section entails that the laboratory fulfills the impartiality and confidentiality standards for the ISO 17025. The general requirements provide that laboratory activities must be adequately organized, structured, and handled to ensure impartiality to avoid biased results from being created. A testing laboratory is charged with ensuring the impartiality of its laboratory activities. I also prevent commercial, financial, or relationship pressures that may jeopardize its impartiality and confidentiality. The laboratory is required to notify its customers before it puts out their customer’s personal information in the public domain, ensuring that the customer’s personal information is protected.
2. Structural requirements
The structural requirements provide that the laboratory must be a legal entity. These requirements address the laboratory’s organizational structure and define the responsibility, authority, and interrelationship of all personnel who engage in different aspects of the laboratory’s activities. The different activities, including laboratory activities performed at its permanent facilities, mobile facilities, associated temporary facilities, or customer's facilities, must be performed in accordance with the ISO/IEC 17025:2017 requirements.
3. Resource requirements
Under resource requirements, a laboratory must have systems and support services, personnel, facilities, equipment that administers and performs its laboratory activities. The competence requirements, roles, responsibilities, and personnel authorities shall be formulated and communicated to the personnel. The laboratory shall regulate the use of externally provided products and services that influence laboratory activities.
4. Process requirements
Process requirements include the instructions, procedures, guidelines, manuals, standards, and reference data that are of relevance to laboratory activities, comprising:
Handling of Test and Calibration Items
Selection, verification, and validation of methods
Review of Requests, Tenders, and Contracts
Selection, Verification, and Validation of Methods
Evaluation of Measurement Uncertainty
Ensuring the Validity of Results
Control of Data and Information Management
5. Management system requirements
The management system requirements provide that the laboratory shall establish, implement, record, and maintain a management system capable of supporting the constant fulfillment of the ISO/IEC 17025:2017 requirements and ensuring the quality of the laboratory results. The laboratory shall implement a management system consistent with Option A or Option B as defined in the requirements.
Applicants can get a marijuana testing laboratory license from the Hawaii State Department of Health provided they qualify for certification. A medical marijuana testing facility applicant shall provide the following during application:
All information and documentation required by the department. The required information and documentation are specified in the Medical Cannabis Testing Facility Application form. Some of the required information are:
The electronic version of the required documentation to be submitted with the application and certification fee are:
A copy of the testing facility’s most recent assessment by the testing facility’s accreditation body and the testing facility’s responses to any discoveries of non-compliance with standards or recommendations; and
A copy of the laboratory's accreditation in Hawaii or another jurisdiction, accompanied by the scope of accreditation.
The completed form must be signed, dated, and packaged with the necessary documentation. The application packet and fee should be submitted by certified mail to:
State Laboratories Division
2725 Waimano Home Road
Pearl City, Hawaii 96782
After the completed application form has been submitted alongside the required documentation and fee, the testing facility will undergo an on-site inspection and evaluation. The applicant will also be required to demonstrate capacity and proficiency to test cannabis and cannabis products before the State Department of Health Can approve them. The department shall not approve the application for certification if the laboratory does not meet the set requirements.
When the Hawaii State Department of Health certifies a laboratory, the laboratory is required to:
The certification fee for a marijuana testing laboratory is $3,000, and it is to be paid to the Hawaii State Department of Health via certified check, cashier’s check, or money order. It should be noted that personal and company checks will not be accepted. A marijuana testing laboratory certification shall expire one year after the date it was issued, but it may be renewed if the laboratory:
A marijuana testing facility’s certification may be extended beyond the one-year expiration at the department’s discretion if the laboratory timely requests renewal of its certification and approves the extension in writing prior to the expiration date.
There are no local regulations for cannabis testing laboratories in Hawaii. Cities and counties do not locally regulate cannabis testing facilities for chemical exposure, air quality, odor control, ventilation requirements, standards, etc. Cannabis testing facilities in Hawaii are centrally certified and regulated by the Hawaii State Department of